FDA Recall
Terminated
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Recall: Z-1159-2010
·
Initiated October 1, 2005
Recall
- Recall Number
- Z-1159-2010
- Event Number
- 54559
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 1, 2005
- Posted
- March 18, 2010
- Terminated
- March 25, 2010
- Address
- 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011
Description
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason
Customer reported larger than expected variations in wedge factory with gantry rotation.
Action
Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.
Distribution
United States, Canada and Mexico.
Quantity
315 units